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May 29 to June 2 in Chicago
Redefining Innovation with Bayesian Statistics
Inspired by Thomas Bayes, we transform uncertainty into opportunity for modern clinical development.
Discover Our Solutions"It is possible to calculate rational degrees of belief from incomplete information."
Cogitars - The Bayesian Experts!
Specialized statistical support for innovative development in pharmaceuticals, medical devices, and diagnostics.
Bayesian Statistics for Dose Escalation
We offer model-based approaches for dose escalation studies, including optimization and Bayesian decision rules for Phase 3 studies. Our methods have been proven to work in practice across numerous clinical trials.
Bayesian Statistics for Dose Optimization (Project Optimus)
We support FDA’s Project Optimus with model-based dose optimization using Bayesian methods, integrating pharmacokinetics, pharmacodynamics, efficacy, and safety to identify optimal, patient-centered dosing.
Bayesian decision rules for Phase 2/3 studies.
We implement Bayesian decision-making frameworks in Phase 2 and 3 trials to enable early, data-driven go/no-go decisions. By incorporating efficacy, safety, and prior evidence, our methods improve trial efficiency and support more informed development strategies..
Statistical Support for Clinical Trials including Estimand framework
Comprehensive statistical support for Phase 1/2 and 3 studies, helping biotechnology companies make better use of their data to improve the development of their compounds.
Visual Trial Monitoring & Reporting
Advanced visual trial monitoring and reporting using Python/R and AI technologies, providing real-time insights and data visualization for clinical operations teams. And report generation with CDISC Standards (SDTM and ADAM)
DMC/DSMB/HTA Support
Expert Data (Safety) Monitoring Board (DMC/DSMB) support with extensive experience across different indications, ensuring proper safety oversight for your clinical trials. Supporting your HTA dossier with robust, transparent, and scientifically grounded statistical methodology. We ensure that your evidence package stands up to scrutiny by integrating best-in-class statistical approaches tailored to payer expectations.
Our Services
We provide specialized statistical support for biotechnology companies, with a focus on clinical trial design, monitoring, and analysis.
Bayesian Statistics for clinical Studies
We specialize in model-based approaches for dose escalation studies, providing more efficient and accurate methods than traditional designs. Our expertise includes:
Model-Based Approaches
Fully Bayesian, adaptive dose-escalation for single agent or combination treatments incorporating pre-clinical or existing historical information.
Dose Optimization
Advanced methods for identifying optimal dosing strategies, including those aligned with FDA's Project Optimus.
Bayesian Decision Rules for Phase 3
Implementation of Bayesian decision rules for Phase 3 studies, enabling more efficient trial designs and better-informed go/no-go decisions.
Statistical Support for Clinical Trials
Comprehensive statistical support for all phases of clinical development, with particular expertise in:
Phase 1/2 Studies
Expert design and analysis of early-phase studies, including adaptive designs, biomarker analysis, and PK/PD modeling.
Seamless Phase 2/3 Studies
Robust statistical methodology for pivotal trials, including sample size calculations, interim analyses, and regulatory submission support.
Visual Trial Monitoring and Reporting
Advanced data visualization and reporting solutions using Python/R and AI technologies, providing real-time insights for clinical operations teams.
cogiviz Platform
Our advanced data visualization platform provides live access to all Tables, Listings and Figures (TLFs) while the trial is ongoing, with daily automatic data updates from the Electronic Data Centre (EDC).
DSMB/DMC/HTA Support
Expert Data Safety Monitoring Board (DSMB) and Data Monitoring Committee (DMC) support with extensive experience across different indications.
- Experience in DMC/DSMB/HTA in various therapeutic areas
- Experts in adaptive and innovative designs
- Broad experience in communicating statistics with medical experts
- Comprehensive safety monitoring and reporting
Our Why
Better drug development starts with better trial designs.
Inspired by Bayesian thinking, we optimize early-phase development and help build strong foundations for success.
The Problem with the CRO Model
- No specialization in biostatistics
- Small pharma/biotech companies don't get the 'A Team'
- Complicated, inflexible budgets
- Excessive bureaucracy and change orders
- Slow turnaround and delivery times
What We Offer
- A-team level statistical support
- Broader range of advanced statistical tools
- Quick turnaround via process automation
- Flexible, simplified engagement models
Why Statistical Methodology Matters
- Small sample sizes: Data efficiency is key.
- High uncertainty: Good statistics bridge early data gaps.
- Better foundation: Strong Phase 1/2 methods reduce Phase 3 failures (source).
Beyond the 3+3 Design
The traditional 3+3 design only identifies the correct dose about 30% of the time (source).
Our Bayesian methods increase the correct dose identification rate to 70–75%, enhancing trial success and patient safety.
Leadership
Our leadership team brings decades of experience in biostatistics, clinical trials, and pharmaceutical development.
Oliver Schönborn-Kellenberger
Chief Executive Officer
Oliver Schönborn-Kellenberger earned his MSc in Mathematics from Georg August University in Göttingen. He began his career as a statistician at PRA, a CRO, in 2004 before joining Novartis Pharma AG in 2006. In 2008, he transitioned to Novartis Oncology, where he took on responsibility for a major compound in early development. In 2012, he pursued a new opportunity at ImClone International, further expanding his experience in oncology drug development. The following year, in 2013, he embarked on an entrepreneurial journey, leveraging his expertise to drive innovation in the field.
Throughout his career, he has played a pivotal role in the design, execution, and reporting of numerous fully Bayesian single-agent and combination escalation trials, as well as Bayesian Phase II studies. His expertise spans a broad range of statistical methodologies, with a strong focus on Bayesian adaptive designs, dose-finding strategies—including those aligned with FDA's Project Optimus—and predictive modeling to optimize clinical development strategies.
With extensive experience in oncology and hematology, he has contributed to the approval, conduct, and reporting of over 50 fully Bayesian Phase 1/2 studies. His work has encompassed a diverse range of cancer indications, including solid tumors, Hodgkin's and non-Hodgkin's lymphoma, multiple myeloma, acute myeloid leukemia (AML), glioblastoma, prostate cancer, and vaccine development, among others.
Michael Kruse
Chief Financial Officer
Michael Kruse holds a degree as economist (Diplom Volkswirt) and studied in Hamburg and Liverpool. He joined Cogitars GmbH in 2015. Michael is specialised in building up professional business structures which will be helpful in Cogitars' growth process over the next years. Since Michael worked in Berlin as a consultant for companies in the health sector, he has a deep understanding of both pharmaceutical as well as medtec companies and their business models.
Miguel Pereira MD PhD
Executive Director, Cogitars UK
Miguel is a former physician turned statistician. He holds a MSc in Biostatistics and PhD in Bayesian Statistics applied to epidemiology from Imperial College London. Miguel joined Cogitars in 2021 and, in 2023, opened Cogitars UK, the United Kingdom branch of Cogitars.
In his 10+ years experience in pharma, biotech and medical devices, Miguel has worked as a consultant with UCB, Astrazeneca and the WHO, among others. He has designed and led several Bayesian trials, including the development of novel Bayesian methodology.
Our Values
Our business is guided by our three corporate values which reflect the way we work with our customers.
Empowerment
Empowerment is the key to innovation.
Quality
Quality is the essence of success.
Honesty
Honesty is the foundation of any good business relation.